Exploring the CPCA Framework: Defining Acceptable Intake for NDSRIs

Recent guidance documents from the EMA and FDA introduced the ‘Carcinogenic Potency Categorization Approach (CPCA)’, which given the absence of data, serves as a tiered, structure-based predictive framework for establishing acceptable intake (AI) limits for NDSRIs.
Join us for a comprehensive analysis of the CPCA, which will examine the framework's scope, background, and practical applications through the CPCA prediction module in QSAR Flex. Case studies highlighting the derivation of alternative acceptable intake (AI) limits via surrogates or leveraging other qualified safety data will be presented, offering a detailed look at the scientific rationale behind second-tiered, non-CPCA predictions.

Topics & Speakers:

1. Intro to CPCA Framework within QSAR Flex - Suman Chakravarti, MultiCASE
2. Case studies using CPCA prediction module and surrogates with carcinogenicity data in QSAR Flex, including other considerations to offer a rationale for alternative acceptable intake (AI) limits - Alejandra Trejo-Martin, Gilead Sciences
3. Effect of surrogates with robust carcinogenicity data on establishing the acceptable intake limit for NDSRIs - Roustem Saiakhov, MultiCASE